A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: PRO283698; Drug: placebo

• Registration Number: NCT00888745
• Lead Sponsor: Genentech, Inc.

Brief Summary

This is a Phase I multicenter study that will be conducted in the United States and Europe.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Study Start: 2009-05
• Primary Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• RA diagnosed according to the American College of Rheumatology (ACR)

Exclusion Criteria

• Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
• Clinically significant abnormal ECG
• History of anaphylactic reactions
• Positive hepatitis C antibody or hepatitis B surface antigen
• Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
• A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
• Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
• Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
• Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
• Concomitant therapy with a biologic agent
• Recent exposure to any investigational agent
• Any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
• Hospitalization for a clinically relevant event within the 4 weeks prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PRO283698	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of PRO283698 assessed through the incidence of adverse events	Through study completion or early study discontinuation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	Following study drug administration

Trial Locations

Locations (1)

Investigational Site; 🇭🇺 Szeged, Hungary